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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

The European medicines Agency (EMA) has released a new draft guideline for manufacturers who use bovine serum when producing biologics for human consumption, adding additional testing requirements to screen for bovine viral diarrhea virus (BVDV).

The broader intent of the guideline is to reduce the risk of transmission of bovine spongiform encephalopathy (BSE), also known as mad cow disease, and BVDV, a cattle virus. Though EMA's guideline recommends sponsors use non-ruminant (cow)-based materials, it acknowledges that some materials, and in particular bovine serum, are essential to the manufacture of some biological culturing processes.

Controlling the quality of bovine serum used in biologics manufacturing, then, is of the utmost importance to stem the risk of transmitting BSE, BVDV and other "deleterious effects."

Traceability, Testing Key Requirements of Guideline

Serum-commonly foetal bovine serum (FBS)-should only be collected by trained personnel using specified methods. Strong oversight of an animal's supply chain should also be used to ensure they come from regional or national control programs meant to minimize the use of unsafe feeding or slaughter methods that can transmit BSE or BVDV.

This is particularly important when establishing a product's pedigree, explains EMA. "The traceability of serum from final container back to the abattoir of origin is of prime importance and a clear audit trail must be demonstrable including records of volumes at each stage. Traceability of serum from final container to farm of origin should be ensured for donor herds used to obtain Donor Bovine Serum."

A certificate for traceability purposes should show the catalogue number, batch number, country of origin of all source animals, final batch volume, data of manufacture, the product's shelf life, certification that a serum is bovine-only and information on the physico-chemical properties of the serum.

BVDV Testing

Though BSE testing has long been a requirement for manufacturing serum in the EU, EMA's new draft guideline also adds a requirement for BVDV testing as well.

Regulators note that the detection of the virus is difficult and its presence in a bovine serum, "Cannot completely be avoided." That being said, EMA explains that any contaminants found should be inactivated or removed before the serum is retested.

The final serum should be free from all viral, fungal, bacterial or mycoplasma contaminants.

Sponsors should also be wary of anti-BVDV antibodies, which can mask the presence of BVDV in a serum. The use of validated testing for all detection methods is required, added EMA.

Though the guideline applies specifically to serum obtained from bovine species, its principles are applicable to serum obtained from other species for similar purposes, such as horses.